Coronary Bypass Marker 10-696

GUDID B776106961

Suturing Washer

FIRST CALL, INC.

Metallic coronary bypass marker, non-sterile Metallic coronary bypass marker Metallic coronary bypass marker Metallic coronary bypass marker Metallic coronary bypass marker Metallic coronary bypass marker Metallic coronary bypass marker Metallic coronary bypass marker Metallic coronary bypass marker Metallic coronary bypass marker

Primary Device ID	B776106961
NIH Device Record Key	3aee9866-a13e-4c4d-b860-8e3fe3868d13
Commercial Distribution Status	In Commercial Distribution
Brand Name	Coronary Bypass Marker
Version Model Number	Rev1
Catalog Number	10-696
Company DUNS	015526185
Company Name	FIRST CALL, INC.
Device Count	3
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B776106961 [Primary]
HIBCC	B7761069619 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K052642

FDA Product Code

MAB	Marker, Cardiopulmonary Bypass (Vein Marker)